Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter’s Transformation or Richter’s Syndrome Patients

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Brief Title

Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients

Official Title

Two-arm Phase II Trial Exploring the Use of the Targeted Agents Ibrutinib and Obinutuzumab for the Treatment of Patients With a Diagnosis of Richter's Transformation (RT) or Richter's Syndrome (RS)

Brief Summary

      This research study studies the combination of ibrutinib and obinutuzumab with or without the
      standard chemotherapy regimen of CHOP to see how well these drugs work in treating patients
      with a diagnosis of Richter's Transformation or Richter's Syndrome. The Bruton's Tyrosine
      Kinase (BTK) inhibitor, ibrutinib, may stop growth of cancer cells by blocking the signal
      needed for cell growth. The monoclonal antibody obinutuzumab may block cancer growth by
      targeting cells present in Richter's Transformation. Giving ibrutinib with obinutuzumab may
      be a better treatment for patients with Richter's Transformation. Depending on fitness, the
      patients may receive ibrutinib and obinutuzumab in combination with a regimen known as CHOP
      (C= cyclophosphamide, H= hydroxydaunorubicin (also called doxorubicin), O= oncovin (also
      called vincristine, and P= prednisolone or prednisone (corticosteroids).
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall Response Rate (ORR)

Secondary Outcome

 Number of participants with improved hemoglobin and platelet counts.

Condition

Richter Syndrome

Intervention

Obinutuzumab

Study Arms / Comparison Groups

 Fit arm
Description:  ibrutinib and obinutuzumab in combination with the CHOP regimen

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

3

Start Date

June 19, 2017

Completion Date

September 28, 2018

Primary Completion Date

September 28, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  confirmed Richter's transformation in treatment naïve and previously treated chronic
             lymphocytic leukemia/small lymphocytic lymphoma patients

          -  may have had prior exposure to ibrutinib and other B-cell signaling receptor agents

          -  Adequate hematologic function

          -  Adequate liver and kidney function

          -  Willing and able to participate in all required evaluations and procedures in this
             study protocol

          -  Female subjects of childbearing potential must not be pregnant upon study entry

          -  Male and female subjects who agree to use highly effective methods of birth control

        Exclusion Criteria:

          -  known allergy to any of medications

          -  chemotherapy taken within 21 days of study treatment

          -  targeted therapy within 10 days of study treatment

          -  BCR inhibitors within 24 hours of study treatment

          -  major surgery within 4 weeks of first dose of study treatment

          -  women who are pregnant

          -  known infection with HIV or Hepatitis C

          -  Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Jacqueline Barrientos, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03145480

Organization ID

16-727


Responsible Party

Principal Investigator

Study Sponsor

Northwell Health

Collaborators

 Pharmacyclics LLC.

Study Sponsor

Jacqueline Barrientos, MD, Principal Investigator, Northwell Health


Verification Date

February 2019